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The ECOM (Endotracheal Cardiac Output Monitoring) System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM Endotracheal Tube. The ECOM System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used.

The ECOM (Endotracheal Cardiac Qutput Monitoring) System consists of an ECOM Endotracheal Tube, which contains the electrodes, an ECOM Monitor, an ECOM Tube Cable, and a Laptop Computer. The ECOM System is used in conjunction with a commercially available arterial pressure (AP) line and 3 surface leads on the patient's chest for R-Wave Detection. The Instructions For Use in Appendix 1 includes pictures of each of these components.

The ECOM System is intended for the continuous monitoring of cardiac output by a specially designed endotracheal tube using the principle of bioimpedance (impedance cardiography). Bioimpedance is based on the principal that all biological tissues. including blood, muscle, bone and fat, have electrical properties. Of these, blood is one of the most electrically conductive. Because arterial blood is pulsatile, changes in blood flow result in changes in electrical conductivity and hence the impedance of the blood to electrical current.

The ECOM System measures impedance by injecting a small alternating electrical current (100kHz, 4.0mA) between a pair of electrodes located on the shaft and cuff of the ECOM Endotracheal Tube. Additional electrodes on the ECOM Endotracheal Tube sense the change of impedance caused by changes of the aortic blood flow.

A proprietary ECOM algorithm is used to calculate ventricular stroke volume (SV) from the impedance and arterial pressure waveforms. The stroke volume is multiplied by the patient's heart rate (HR) to calculate cardiac output (CO) in liters per minute. In addition to these parameters, ECOM displays traces of the impedance waveforms, R-Wave Detection signals, systolic and diastolic arterial pressure.

The ECOM Endotracheal Tube contains seven low profile, flexible electrodes affixed to the cuff and shaft of a Standard Endotracheal Tube. The close proximity of the endotracheal tube balloon cuff in relationship to the ascending aorta provides an optimal location from which to measure impedance changes resulting from aortic blood flow.

The ECOM Endotracheal Tube is provided sterile for single use only. It will be available in 6.0mm to 9.0mm sizes, in 0.5mm increments.

The ECOM Monitor, Laptop Computer, ECOM Tube Cable, Lead Wire, Arterial Pressure Cable. Cord Sets, Power Supply, and Power Conditioner are reusable and provided nonsterile.

The provided text describes the ECOM Endotracheal Cardiac Output Monitor. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for the ECOM System's performance (e.g., a specific percentage accuracy or an agreement threshold). Instead, it aims to demonstrate "substantial equivalence" to predicate devices. The reported device performance is described qualitatively as being "substantially equivalent at estimating cardiac output as are the predicate non/less invasive devices."

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify the exact number of patients or cardiac output measurements in the final clinical study (test set). It states, "For this study, time matched data for the ECOM System and pulmonary artery catheters were obtained, which provided multiple thermodilution cardiac output measurements." This implies a dataset with paired measurements, but the exact size is not given.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was framed as "the final step of a three-phase clinical development program" and states, "Imagyn's ECOM System is a new system for the measurement of CO that has been tested in human subjects," confirming prospective clinical data collection for the final validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• The ground truth for the test set was established using pulmonary artery catheters (Swan-Ganz catheters) and thermodilution cardiac output measurements. These are considered a standard clinical method for measuring cardiac output, rather than relying on human expert adjudication of images or waveforms.
• Therefore, the concept of "number of experts" and "qualifications of experts" in the context of establishing ground truth for the ECOM System's accuracy against this invasive gold standard does not directly apply here. The expertise lies in the proper use and interpretation of the thermodilution method.

4. Adjudication Method for the Test Set

• There was no human adjudication method (e.g., 2+1, 3+1). The ground truth was established by another medical device (pulmonary artery catheter using thermodilution), which provides objective numerical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not performed. This type of study typically involves human readers interpreting diagnostic outputs (like images) and is not relevant for a device that directly measures physiological parameters like cardiac output. The study focused on the agreement between the ECOM system and a reference standard (pulmonary artery catheter).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, the clinical study described is effectively a standalone performance study. The ECOM System, through its proprietary algorithm, calculates cardiac output. The study then compares these calculated values directly against a reference standard (thermodilution measurements from pulmonary artery catheters) without direct human interpretation influencing the ECOM's output. Human users read the result from the device, but the device itself operates in a standalone manner to generate that result.

7. The Type of Ground Truth Used

• The ground truth used was outcomes data / reference device measurements, specifically "multiple thermodilution cardiac output measurements" obtained from "pulmonary artery catheters." This is a generally accepted clinical gold standard for cardiac output measurement.

8. The Sample Size for the Training Set

• The document states that "The two earlier phases were necessary to develop an algorithm for clinical applications and to calibrate the algorithm using actual clinical data." However, it does not specify the sample size for the training set (the data used in these earlier phases).

9. How the Ground Truth for the Training Set was Established

• The document states that the earlier phases were used to "develop an algorithm for clinical applications and to calibrate the algorithm using actual clinical data." It is highly probable that the ground truth for this training and calibration data was also established using clinical reference methods similar to or identical to the ground truth used in the final test set (e.g., pulmonary artery catheters and thermodilution), as this would be standard practice for developing and tuning such a device. However, this is not explicitly detailed for the training set in the provided text.

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SiteSelect® is a disposable, single use diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from its mammographic appearance. Therefore, it is essential that the tissue margins be examined for margin involvement and completeness of removal in cases where the tissue sample is not found to be benign.

SiteSelect is to be used in conjunction with a stereotactic mammographic imaging system capable of determining position of lesion within breast tissue.

This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.

SiteSelect Breast Biopsy System consists of the SiteSelect device and the Site Select table mount accessories. We have previously received clearance under 510(k) # K972328 for the 10mm and 15mm SiteSelect device. We have since received clearance under 510(k) #K993963 to expand the intended use. The Instrument Accessories have received clearance under 510(k) # K972328 and are currently on the market.

The SiteSelect device is provided sterile for single use only. It contains a Localization Needle, Localization Wire, a Stylet, and Cutting Cannula. The device is equipped with a Garrote Wire and Disc Blades to transect the specimen. The device is packaged in individual thermoformed blisters with peel off Tyvek® lid.

Here's a summary of the acceptance criteria and the study backing the SiteSelect Breast Biopsy Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided 510(k) summary (K011575) for the 22mm SiteSelect Breast Biopsy Device does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for performance metrics. Instead, the study's primary goal was to demonstrate comparability to a legally marketed predicate device (the 15mm SiteSelect device).

The "acceptance criteria" can be inferred from the stated conclusions: that the 22mm device is safe for its intended use, has accurate targeting of selected tissue, captures adequate tissue specimens for histological analysis, and is comparable to the 15mm SiteSelect device with no significant variances in key clinical categories.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Study Details:

This submission describes a clinical study comparing the new 22mm SiteSelect device to the existing 15mm SiteSelect device.

1. Sample Size used for the test set and the data provenance:

   • Test Set Size: A total of 50 procedures were completed, with 25 procedures using the 22mm device and 25 procedures using the 15mm device.
   • Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as procedures were "completed" for the purpose of the comparison.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not provide details on the number of experts or their qualifications for establishing the "ground truth." However, it states that "Specimens were suitable for pathological analysis," implying that pathologists (experts) would have performed this analysis.

3. Adjudication method for the test set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "comparable" assessment likely refers to a direct comparison of the collected data points without explicit expert adjudication of conflicting results.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This was a clinical study comparing two medical devices for biopsy, not an AI-based imaging study involving human readers. Therefore, an MRMC study and AI-related effect sizes are not applicable here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This device is a manual biopsy instrument and does not involve an algorithm. Its performance is directly tied to human use in a medical procedure.

6. The type of ground truth used:

   • The ground truth primarily relates to histological analysis of the tissue specimens obtained. The study also evaluated clinical parameters like targeting accuracy, pain, and follow-up appearance, which rely on direct observation and patient reporting during the procedure and follow-up visits.

7. The sample size for the training set:

   • This was a clinical study comparing a new device size to an existing one. It is not an algorithm development study, so the concept of a "training set" in the context of machine learning does not apply.

8. How the ground truth for the training set was established:

   • As this is not an algorithm development study, the concept of establishing ground truth for a training set is not applicable. The "ground truth" for the clinical study was based on the pathological analysis of the biopsy specimens and clinical observations during the procedures and follow-up.

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SiteSelect is a disposable, single use, diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/ localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from it's mammographic appearance. Therefore, it is essential that the tissue margins be examined for margin involvement and completeness of removal in cases where the tissue sample is not found to be benign.

SiteSelect is to be used in conjunction with stereotactic mammographic imaging systems capable of determining position of lesion within breast tissue.

This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.

The SiteSelect device, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These devices are marketed by Imagyn Surgical and United States Surgical Corporation (USSC).

SiteSelect, Imagyn Surgical, and USSC devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are used with stereotactic mammographic imaging systems.

The construction, materials, sterilization, and method of operation of the SiteSelect devices are identical to the Imagyn Surgical SiteSelect devices currently on the market.

The major difference between SiteSelect and USSC ABBI devices is that the ABBI device removes tissue in route to and including the target area. The SiteSelect device obturates up to the lesion, leaving intact the tissue in route to the target area.

The provided text describes the SiteSelect breast biopsy device and its 510(k) submission for market clearance. It focuses on demonstrating substantial equivalence to existing devices and presents a clinical summary. However, it does not explicitly define acceptance criteria for device performance in the context of diagnostic accuracy, nor does it present a study specifically designed to prove the device meets such criteria with quantitative metrics like sensitivity or specificity.

The clinical summary describes the device's usage and outcomes in a patient cohort, but this is presented as an evaluation of the device for use in removing abnormalities for diagnostic evaluation, rather than a test against pre-defined performance thresholds.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria are provided in the document for diagnostic performance metrics (e.g., sensitivity, specificity, PPV, NPV). The document's purpose is to demonstrate substantial equivalence and usability, not to establish diagnostic performance against specific targets.

The "device performance" in the clinical summary relates to the ability to obtain tissue and the subsequent histological findings.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 87 patients.
• Data Provenance: The study was a "multi-center, non-randomized study" collected from "3 sites." The country of origin is not specified, but the FDA submission suggests it was likely
  conducted in the United States. The study was prospective as it involved patients undergoing procedures to evaluate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish the ground truth. It states that "malignant lesions" were "diagnosed," which implies pathological examination. The qualifications of these experts (e.g., pathologists) are not provided.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Diagnosis of malignancy would typically come from a pathology report, which serves as the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on the device's ability to obtain biopsies and the subsequent diagnostic findings, not on comparing reader performance with or without AI assistance. The SiteSelect device is a physical biopsy tool, not an AI-assisted diagnostic tool for image interpretation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The SiteSelect is a physical medical device (a disposable breast biopsy device), not an algorithm or AI. Therefore, a standalone study of an algorithm's performance is not relevant in this context. The clinical summary describes its use in conjunction with human healthcare providers.

7. The Type of Ground Truth Used

The ground truth for the diagnosis of malignancy was pathology (histological examination), as indicated by the statement "diagnosed with malignant lesions" and the subsequent "surgical procedure after diagnostic SiteSelect procedure," implying confirmation of the diagnosis.

8. The Sample Size for the Training Set

Not applicable. The SiteSelect device is a physical, disposable breast biopsy device, not a machine learning model or algorithm that requires a training set. The clinical study described is for evaluating the device's use in tissue acquisition and diagnosis in patients.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is a physical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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